MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX24CM HEMO-CATH

Model Number MC101243

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Air bubbles noted to both lumens of cvad above and below clamp.Line last flushed 48 hours ago, with no access to cvc after flushing.No cracks, leaks or issues noted to integrity of line.Line care provided including removal of air, flushing as per protocol.Line remains insitu and to be monitored for further air leaks.Staff have identified that the caps that are provided in the kit are the issue.They have since switched to a different cap with no further air in-line concerns.

Manufacturer Narrative

The device involved in the incident was not returned as it remains implanted in the patient.The report indicated that the catheter involved did not leak and was implanted for 19 days before the issue was noted.The photograph that was provided and showed air bubbles in the extension lines.Some of the photographs depict end caps that are not manufactured or supplied by medcomp.The end caps provided in the kits are one-time use, are not meant to be injected through and should be changed after each treatment.If this was followed the end caps provided in the kits could not be the cause of the air bubbles in the extensions.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the devices were manufactured according to specification with no non-conformances or abnormalities.The manufacture process includes a leak test as well as a test for air bubbles.The catheter female luers are manufactured to the iso standard.They are universal female luers and will mate with any universal male luer of bloodlines, syringes, end caps, etc.If they are also manufactured to the iso standard.These end caps are packaged in all of medcomp's long- and short-term hemodialysis/apheresis catheter kits.No other reports of this nature have been received.Without evaluations of the device involved we are unable to determine if the catheter contributed to the problem.After evaluating the information provided, we believe it is unlikely the catheter is at fault.This conclusion was reached since the facility indicated that switching caps ended the problem.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12.5FX24CM HEMO-CATH
• Type of Device: HEMO-CATH
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 12154610
• MDR Text Key: 262169772
• Report Number: 2518902-2021-00037
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908083002
• UDI-Public: 884908083002
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/30/2021
• Device Model Number: MC101243
• Device Catalogue Number: MC101243
• Device Lot Number: MPFT860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention